MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2016-07-27 for ARGUS II RETINAL PROSTHESIS 011014-007-K 011014 manufactured by Second Sight Medical Products, Inc..
[50575927]
All pertinent information available to second sight medical products, inc. Has been submitted. The company is submitting this mdr to ensure full compliance with 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[50575928]
This patient was implanted with an argus ii device on (b)(6) 2015 as part of a clinical trial for amd subjects. On (b)(6) 2016, the patient reported experiencing blurry vision and discomfort in the implanted eye. On (b)(6) 2016, patient's was diagnosed with hypotony (intraocular pressure was 5 mmhg) and inflammation, and was prescribed steroids and antibiotic topical treatments. On (b)(6) 2016, a surgical intervention was conducted during which intravitreal gas was injected into the eye. On (b)(6) 2016, a second revision surgery was conducted during which the sclerotomy was re-sutured, the scleral patch graft was replaced, and an air bubble was injected. Following the surgery, the surgeon reported that the patient's intraocular pressure in the implanted eye has remained stable at 10 mmhg. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[54345379]
This event represents a follow-up report to mdr# 3004081696-2016-00011. All pertinent information available to second sight medical products, inc. Has been submitted. The company is submitting this mdr to ensure full compliance with 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[54345380]
This patient experienced hypotony in the implanted eye, and underwent two revision surgeries on (b)(6) 2016, respectively. New information: on (b)(6) 2016, it was reported that the patient's intraocular pressure (iop) had been 8-10 mmhg in the 2 weeks following the second revision surgery conducted on (b)(6) 2016. On (b)(6) 2016, a third revision surgery was conducted during which a vitrectomy and silicone oil injection was performed. On (b)(6) 2016, the patient's iop was 12 mmhg and the surgeon reported a marked improvement with no inflammation. The patient's retina was fully attached and the implant was in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004081696-2016-00011 |
| MDR Report Key | 5826756 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2016-07-27 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-06-27 |
| Date Mfgr Received | 2016-06-27 |
| Device Manufacturer Date | 2014-11-06 |
| Date Added to Maude | 2016-07-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK LOAR |
| Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8188335049 |
| Manufacturer G1 | SECOND SIGHT MEDICAL PRODUCTS, INC. |
| Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGUS II RETINAL PROSTHESIS |
| Generic Name | RETINAL PROSTHESIS |
| Product Code | NBF |
| Date Received | 2016-07-27 |
| Model Number | 011014-007-K |
| Catalog Number | 011014 |
| Lot Number | N/A |
| Device Expiration Date | 2016-11-06 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECOND SIGHT MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 12744 SAN FERNANDO RD. SUITE 400 SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-07-27 |